NCT05052970

Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM

A Phase Ⅰ Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.

Detailed description

This is a multicenter, open-label, phase I study aimed to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. In the study, 60 patients will be recruited into three dose groups. All patients will receive the treatment for the planned 8 cycles(28 days per cycle）until disease progression or unacceptable drug-related adverse events

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome injection	Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
DRUG	Bortezomib for Injection	Bortezomib (1.3 mg/m\^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
DRUG	Dexamethasone Acetate Tablets	Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle

Timeline

• Start date: 2021-10-20
• Primary completion: 2023-04-20
• Completion: 2024-06-20
• First posted: 2021-09-22
• Last updated: 2022-02-01

Locations

1 site across 1 country: China